Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial

Resumo Introdução e objetivos: Stents Coated with the Biodegradable Polymer on their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions (Destiny Trial) é um estudo randomizado de não inferioridade que comparou o stent farmacológico eluído com Sirolimus Inspiron® (SES) ao controle o stent Biomatrix® Flex eluído com biolimus (BES). Relatórios dentro do primeiro ano mostraram resultados semelhantes para ambos os stents, em seguimento clínico, angiográfico e também em análise de tomografia de coerência ótica e ultrassom intracoronário. A presente análise tem como objetivo comparar o desempenho clínico desses dois stents farmacológicos com polímeros biodegradáveis após cinco anos do procedimento índice. Métodos: Foram randomizados 170 pacientes (194 lesões) em uma proporção de 2:1 para trata mento com SES ou BES, respetivamente. O desfecho primário para o presente estudo foi a taxa em cinco anos de eventos cardíacos adversos maiores combinados, definida como morte cardíaca, infarto do miocárdio ou revascularização da lesão-alvo. Resultados: Em cinco anos, o desfecho primário ocorreu em 12,5% e 17,9% para o grupo SES e BES, respectivamente (p=0,4). Não houve trombose de stent definitiva ou provável entre os pacientes tratados com o novo SES durante os cinco anos de seguimento e ausência de trombose de stent após o primeiro ano no grupo BES. Conclusões: O novo stent Inspiron® apresentou uma boa e semelhante performance clínica no seguimento em longo prazo, quando comparado com o controle o stent de última geração Biomatrix® Flex.

Implications for Clinical Practice from a Multicenter Survey of Heart Failure Management Centers.

OBJECTIVES: This observational, cross-sectional study based aimed to test whether heart failure (HF)-disease management program (DMP) components are influencing care and clinical decision-making in Brazil. METHODS: The survey respondents were cardiologists recommended by experts in the field and invited to participate in the survey via printed form or email. The survey consisted of 29 questions addressing site demographics, public versus private infrastructure, HF baseline data of patients, clinical management of HF, performance indicators, and perceptions about HF treatment. RESULTS: Data were obtained from 98 centers (58% public and 42% private practice) distributed across Brazil. Public HF-DMPs compared to private HF-DMP were associated with a higher percentage of HF-DMP-dedicated services (79% vs 24%; OR: 12, 95% CI: 94-34), multidisciplinary HF (MHF)-DMP [84% vs 65%; OR: 3; 95% CI: 1-8), HF educational programs (49% vs 18%; OR: 4; 95% CI: 1-2), written instructions before hospital discharge (83% vs 76%; OR: 1; 95% CI: 0-5), rehabilitation (69% vs 39%; OR: 3; 95% CI: 1-9), monitoring (44% vs 29%; OR: 2; 95% CI: 1-5), guideline-directed medical therapy-HF use (94% vs 85%; OR: 3; 95% CI: 0-15), and less B-type natriuretic peptide (BNP) dosage (73% vs 88%; OR: 3; 95% CI: 1-9), and key performance indicators (37% vs 60%; OR: 3; 95% CI: 1-7). In comparison to non- MHF-DMP, MHF-DMP was associated with more educational initiatives (42% vs 6%; OR: 12; 95% CI: 1-97), written instructions (83% vs 68%; OR: 2: 95% CI: 1-7), rehabilitation (69% vs 17%; OR: 11; 95% CI: 3-44), monitoring (47% vs 6%; OR: 14; 95% CI: 2-115), GDMT-HF (92% vs 83%; OR: 3; 95% CI: 0-15). In addition, there were less use of BNP as a biomarker (70% vs 84%; OR: 2; 95% CI: 1-8) and key performance indicators (35% vs 51%; OR: 2; 95% CI: 91,6) in the non-MHF group. Physicians considered changing or introducing new medications mostly when patients were hospitalized or when observing worsening disease and/or symptoms. Adherence to drug treatment and non-drug treatment factors were the greatest medical problems associated with HF treatment. CONCLUSION: HF-DMPs are highly heterogeneous. New strategies for HF care should consider the present study highlights and clinical decision-making processes to improve HF patient care.

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial.

INTRODUCTION AND OBJECTIVES: The Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. METHODS: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. RESULTS: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. CONCLUSIONS: The novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.

Absorb bioresorbable vascular scaffold outcomes following implantation with routine intravascular imaging guidance.

OBJECTIVES: We sought to describe the outcomes of BVS use from a single-center experience in which scaffold implantation was guided by intravascular imaging (ultrasound and/or optical coherence tomography) to identify and treat mechanical factors potentially related to BVS failure. BACKGROUND: The Absorb bioresorbable vascular scaffold (BVS) has been associated with an unexpectedly high incidence of thrombosis. METHODS: Between 11/2014 and 10/2016, 100 patients were treated with BVS. Intravascular imaging assessment before and after BVS implantation was performed in all cases. RESULTS: Mean age was 58.1 years; 88% were male, 31% had diabetes, and 28% presented with acute coronary syndromes. A total of 171 lesions in 141 vessels were treated with 190 BVS (mean 1.9 scaffolds/patient). Further intervention following intravascular imaging to optimize BVS implantation was required in 31% of patients. Procedure success was 100%. All patients completed a 1-year follow-up. The 1-year rate of target lesion failure was 4%, and there were no cases (0%) of scaffold thrombosis, myocardial infarction, or death. CONCLUSIONS: In this real-world experience, the use of intravascular imaging to guide BVS implantation was associated with a high 1-year event-free survival rate, with no scaffold thrombosis.

Implications for clinical practice from a multicenter survey of heart failure management centers

OBJECTIVES: This observational, cross-sectional study based aimed to test whether heart failure (HF)-disease management program (DMP) components are influencing care and clinical decision-making in Brazil. METHODS: The survey respondents were cardiologists recommended by experts in the field and invited to participate in the survey via printed form or email. The survey consisted of 29 questions addressing site demographics, public versus private infrastructure, HF baseline data of patients, clinical management of HF, performance indicators, and perceptions about HF treatment. RESULTS: Data were obtained from 98 centers (58% public and 42% private practice) distributed across Brazil. Public HF-DMPs compared to private HF-DMP were associated with a higher percentage of HF-DMP-dedicated services (79% vs 24%; OR: 12, 95% CI: 94-34), multidisciplinary HF (MHF)-DMP [84% vs 65%; OR: 3; 95% CI: 1-8), HF educational programs (49% vs 18%; OR: 4; 95% CI: 1-2), written instructions before hospital discharge (83% vs 76%; OR: 1; 95% CI: 0-5), rehabilitation (69% vs 39%; OR: 3; 95% CI: 1-9), monitoring (44% vs 29%; OR: 2; 95% CI: 1-5), guideline-directed medical therapy-HF use (94% vs 85%; OR: 3; 95% CI: 0-15), and less B-type natriuretic peptide (BNP) dosage (73% vs 88%; OR: 3; 95% CI: 1-9), and key performance indicators (37% vs 60%; OR: 3; 95% CI: 1-7). In comparison to non- MHF-DMP, MHF-DMP was associated with more educational initiatives (42% vs 6%; OR: 12; 95% CI: 1-97), written instructions (83% vs 68%; OR: 2: 95% CI: 1-7), rehabilitation (69% vs 17%; OR: 11; 95% CI: 3-44), monitoring (47% vs 6%; OR: 14; 95% CI: 2-115), GDMT-HF (92% vs 83%; OR: 3; 95% CI: 0-15). In addition, there were less use of BNP as a biomarker (70% vs 84%; OR: 2; 95% CI: 1-8) and key performance indicators (35% vs 51%; OR: 2; 95% CI: 91,6) in the non-MHF group. Physicians considered changing or introducing new medications mostly when patients were hospitalized or when observing worsening disease and/or symptoms. Adherence to drug treatment and non-drug treatment factors were the greatest medical problems associated with HF treatment. CONCLUSION: HF-DMPs are highly heterogeneous. New strategies for HF care should consider the present study highlights and clinical decision-making processes to improve HF patient care.

Correlação entre as lesões coronarianas diagnosticadas pela angiotomografia e as diagnosticadas pelo método visual da cineangiocoronariografia / Correlation between coronary injuries diagnosed by multislice CT coronary angiography and diagnosed by visible coronary cineangiography method

Avaliar a eficácia diagnóstica da angiotomografia coronariana (AC) comparada com a cineangiocoronariografia (CAT). Material e Métodos: Foram avaliados retrospectivamente 146 pacientes submetidos a AC e CAT com angiografia coronariana quantitativa (ACQ), com intervalo médio de um mês entre os exames. O estudo foi realizado no Hospital Cardiológico Costantini. Foram avaliados os fatores de risco da amostra, a localização das lesões e o grau de severidade da obstrução coronariana nos grandes vasos (TCE, DA, CX e CD). Os resultados dos métodos diagnósticos foram comparados pelo coeficiente de correlação de Pearson. A partir dos achados positivos foi realizada a avaliação de correlação entre os métodos perante a severidade das lesões. Resultados: A amostra foi composta predominantemente por homens (73,97%), sendo a hipertensão arterial (HAS) (71,91%) o fator de risco mais frequente. A artéria mais acometida foi a DA. Quanto ao grau de severidade das lesões, os resultados foram os seguintes na comparação entre AC e CAT: lesões discretas com correlação r = 0,23; moderadas com r = 0,53 e severas com r = 0,70. Na comparação entre AC e ACQ: lesões discretas com correlação r = 0,45; moderadas com r = 0,70 e severas com r = 0,67. Conclusão: A AC apresentou moderada com ACQ e CAT em lesões moderadas e severas, e forte correlação na ausência de lesões quando comparada com ACQ

To evaluate the diagnostic efficacy of multislice CT coronary angiotomography compared with coronary cineangiography. Material and Methods: We retrospectively evaluated 146 patients submitted to MSCT and CA with quantitative coronary angiography (QCA), with a mean interval of one month between the exams. The study was carried out at the Costantini Cardiology Hospital. The risk factors for the sample, the location of the lesions and the degree of severity of the coronary obstruction in the large vessels (LCT, AD, CX and RC).The results of the diagnostic methods were compared using Pearson correlation coefficient. From the positive findings, a correlation evaluation was performed between the methods for the severity of the lesions. Results: The sample consisted predominantly of men (73.97%), and hypertension (SAH) (71.91%) was the most frequent risk factor. The most affected artery was AD. Regarding the degree of severity of the lesions, the results were as follows in the comparison between MSCT and CA: mild lesions with correlation r = 0.23, moderate with r = 0.53 and severe with r = 0.70. In the comparison between MSCT and QCA: mild lesions with correlation r = 0.45, moderate with r = 0.70 and severe with r = 0.67. Conclusion: MSCT showed moderate correlation with QCA and CA in moderate and severe lesions, and a strong correlation in the absence of lesions when compared with QCA

Efeito cardiovascular superior do modelo periodizado para prescrição de exercícios comparado ao convencional em coronariopatas / Superior cardiovascular effect of the periodized model for prescribed exercises as compared to the conventional one in coronary diseases

O exercício físico melhora a sobrevida e a qualidade de vida de pacientes coronarianos, mas a maneira ideal de prescrevê-lo é ainda controversa. Criar um modelo periodizado para prescrição de exercícios para pacientes coronarianos e compará-lo com o modelo convencional. Randomização de 62 pacientes coronarianos em tratamento farmacológico em dois grupos: treinamento convencional, não periodizado (GNP, n = 33) e periodizado (GP, n = 29). Os dois grupos foram submetidos aos mesmos exercícios durante as 36 sessões do programa, mas prescritos de maneira diferente. Todos os pacientes foram submetidos à seguinte avaliação: consulta médica admissional, teste de esforço cardiopulmonar, teste de 1 repetição máxima (1RM) e avaliação da composição corporal. O VO2 pico melhorou nos dois grupos, embora de maneira mais efetiva no GP (4% versus 1,7%, p < 0,001). Além disso, a capacidade funcional do GP aumentou em 13%, tendo havido significativa redução no percentual de gordura corporal (2,1%, p < 0,005) e no peso corporal (1,9 kg, p < 0,005). A força muscular nos dois grupos melhorou como diagnosticado pelo teste de 1RM para seis diferentes grupos musculares (quádriceps, isquiotibiais, bíceps, tríceps braquial, peitoral e grande dorsal), mas sem diferença significativa entre os grupos, tendo os dois modelos a mesma eficiência. O presente estudo mostrou que a periodização do treinamento de pacientes cardíacos pode melhorar a capacidade cardiorrespiratória e reduzir a porcentagem de gordura corporal mais efetivamente do que o modelo convencional

Physical exercise improves the survival and quality of life of coronary patients, but the ideal way of prescribing these exercises is still controversial. To create a new periodized model for the prescription of exercises for coronary patients and compare it with a conventional model. 62 coronary patients under pharmacological treatment were randomized into two groups: conventional (NPG, n = 33) and periodized (PG, n = 29) training. The two groups were submitted to the same exercises during the 36 sessions making up the program, but prescribed in different ways. All patients underwent an evaluation consisting of: medical admission consultancy, cardiopulmonary endurance testing, 1 maximum repetition test (1MR) and body composition evaluation. The VO2 peak improved in both groups, although more effectively in the PG (4% against 1.7%, p < 0.001). In addition, the functional capacity of this group improved by 13%, and there was a significant reduction in the percent body fat (2.1%, p < 0.005) and body weight (1.9 kg, p < 0.005). The muscle strength of both groups improved as diagnosed by the 1RM test for six different muscle groups (quadriceps, hamstrings, brachial biceps, brachial triceps, pectoral and large dorsal), and showed no significant difference between the groups, evidencing that the two models had the same efficiency. The present study showed that periodization of the training of cardiac patients can improve their cardiorespiratory capacity and reduce the percent body fat more effectively than the conventional one

Stem-cell therapy in ST-segment elevation myocardial infarction with reduced ejection fraction: A multicenter, double-blind randomized trial.

BACKGROUND: Left ventricular ejection fraction (LVEF) is a major determinant of long-term prognosis after ST-segment elevation myocardial infarction (STEMI). STEMI patients with reduced LVEF have a poor prognosis, despite successful reperfusion and the use of renin-angiotensin-aldosterone inhibitors. HYPOTHESIS: Intracoronary infusion of bone marrow-derived mononuclear cells (BMMC) may improve LVEF in STEMI patients successfully reperfused. METHODS: The main inclusion criteria for this double-blind, randomized, multicenter study were patient age 30 to 80 years, LVEF ≤50%, successful angioplasty of infarct-related artery, and regional dysfunction in the infarct-related area analyzed before cell injection. Cardiac magnetic resonance imaging was used to assess LVEF, left ventricular volumes, and infarct size at 7 to 9 days and 6 months post-myocardial infarction. RESULTS: One hundred and twenty-one patients were included (66 patients in the BMMC group and 55 patients in the placebo group). The primary endpoint, mean LVEF, was similar between both groups at baseline (44.63% ± 10.74% vs 42.23% ± 10.33%; P = 0.21) and at 6 months (44.74% ± 12.95 % vs 43.50 ± 12.43%; P = 0.59). The groups were also similar regarding the difference between baseline and 6 months (0.11% ± 8.5% vs 1.27% ± 8.93%; P = 0.46). Other parameters of left ventricular remodeling, such as systolic and diastolic volumes, as well as infarct size, were also similar between groups. CONCLUSIONS: In this randomized, multicenter, double-blind trial, BMMC intracoronary infusion did not improve left ventricular remodeling or decrease infarct size.

Comparative Study between Perfusion Changes and Positive Findings on Coronary Flow Reserve / Estudo Comparativo entre Alterações de Perfusão e Achados Positivos da Reserva de Fluxo Coronariano

Abstract Background: Functional assessment of coronary artery obstruction is used in cardiology practice to correlate anatomic obstructions with flow decrease. Among such assessments, the study of the coronary fractional flow reserve (FFR) has become the most widely used. Objective: To evaluate the correlation between FFR and findings of ischemia obtained by noninvasive methods including stress echocardiography and nuclear medicine and the presence of critical coronary artery obstruction. Methods: Retrospective study of cases treated with systematized and standardized procedures for coronary disease between March 2011 and August 2014. We included 96 patients with 107 critical coronary obstructions (> 50% in the coronary trunk and/or ≥ 70% in other segments) estimated by quantitative coronary angiography (QCA) and intracoronary ultrasound (ICUS). All cases presented ischemia in one of the noninvasive studies. Results: All 96 patients presented ischemia (100%) in one of the functional tests. On FFR study with adenosine 140 g/kg/min, 52% of the cases had values ≤ 0.80. On correlation analysis for FFR ≤ 0.80, the evaluation of sensitivity, specificity, positive and negative predictive values, accuracy, and ROC curve in relation to the stenosis degree and length, and presence of ischemia, no significant values or strong correlation were observed. Conclusion: Coronary FFR using a cut-off value of 0.80 showed no correlation with noninvasive ischemia tests in patients with severe coronary artery obstructions on QCA and ICUS.

Resumo Fundamento: A avaliação funcional da obstrução arterial coronariana é empregada na prática cardiológica para correlacionar a obstrução anatômica e a queda de fluxo. Dentre as formas de avaliação, o estudo da reserva fracionada de fluxo (RFF) coronariano se tornou a mais utilizada. Objetivo: Avaliar a correlação entre a RFF com achados de isquemia, obtidos por métodos não invasivos como a ecocardiografia de estresse ou medicina nuclear, e a presença de obstrução crítica da artéria coronária. Métodos: Estudo retrospectivo de casos tratados com procedimentos sistematizados e padronizados para doença coronariana entre março de 2011 e agosto de 2014. Foram incluídos 96 pacientes com 107 obstruções coronarianas críticas (> 50% no tronco da coronária e/ou ≥ 70% nos demais segmentos) estimadas por angiografia coronariana quantitativa (ACQ) e ultrassonografia intracoronariana (USIC). Todos os casos apresentaram isquemia em um dos estudos não invasivos. Resultados: Ao estudo da RFF com adenosina na dose de 140 µg/kg/min, valores ≤ 0,80 foram encontrados em 52% dos casos. Na análise de correlação para RFF ≤ 0,80, avaliando-se sensibilidade/especificidade, valor preditivo positivo/negativo, acurácia e curva ROC em relação ao grau de estenose, extensão da estenose e presença de isquemia, não foram observados valores de significância ou de forte correlação. Conclusão: A RFF coronariana a um valor de corte de 0,80 não apresentou correlação com testes não invasivos de isquemia em pacientes com obstruções coronarianas graves à ACQ e USIC.

Comparative Study between Perfusion Changes and Positive Findings on Coronary Flow Reserve.

BACKGROUND: Functional assessment of coronary artery obstruction is used in cardiology practice to correlate anatomic obstructions with flow decrease. Among such assessments, the study of the coronary fractional flow reserve (FFR) has become the most widely used. OBJECTIVE: To evaluate the correlation between FFR and findings of ischemia obtained by noninvasive methods including stress echocardiography and nuclear medicine and the presence of critical coronary artery obstruction. METHODS: Retrospective study of cases treated with systematized and standardized procedures for coronary disease between March 2011 and August 2014. We included 96 patients with 107 critical coronary obstructions (> 50% in the coronary trunk and/or ≥ 70% in other segments) estimated by quantitative coronary angiography (QCA) and intracoronary ultrasound (ICUS). All cases presented ischemia in one of the noninvasive studies. RESULTS: All 96 patients presented ischemia (100%) in one of the functional tests. On FFR study with adenosine 140 g/kg/min, 52% of the cases had values ≤ 0.80. On correlation analysis for FFR ≤ 0.80, the evaluation of sensitivity, specificity, positive and negative predictive values, accuracy, and ROC curve in relation to the stenosis degree and length, and presence of ischemia, no significant values or strong correlation were observed. CONCLUSION: Coronary FFR using a cut-off value of 0.80 showed no correlation with noninvasive ischemia tests in patients with severe coronary artery obstructions on QCA and ICUS.

Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

AIMS: To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating. METHODS: This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively. The primary endpoint was 9-month angiographic in-stent late lumen loss. Adverse clinical events were prospectively collected for 1 year. RESULTS: After 9 months, the novel sirolimus-eluting stent was shown noninferior compared with the biolimus stent for the primary endpoint (angiographic in-stent late lumen loss: 0.20 ± 0.29 mm vs. 0.15 ± 0.20 mm, respectively; P value for noninferiority <0.001). The 1-year incidence of death, myocardial infarction, repeat revascularization, and stent thrombosis remained low and not significantly different between the groups. CONCLUSIONS: The present randomized trial demonstrates that the tested novel sirolimus-eluting stent was angiographically noninferior in comparison with a last-generation biolimus-eluting stent.

Seguimento de 12 meses de pacientes complexos tratados com stentsfarmacológicos liberadores de everolimus XIENCE V® na prática diária – resultados do registro brasileiro BRAVO / Twelve-month follow-up of complex patients treated with the Xience V™ everolimus drug-eluting stents in daily practice – results of the BRAVO Brazilian Registry

O stent liberador de everolimus XIENCE V® é um stent farmacológico de nova geração que incorpora uma plataforma de cromo-cobalto de baixo perfil (81 m) e um polímero de elevada biocompatibilidade (fluoropolímero), o qual carreia e controla a liberação do fármaco everolimus. Estudos recentes demonstram segurança e eficácia sustentadas do dispositivo XIENCE V® no tratamento de populações da prática clínica. Nosso objetivo foi reportar resultados clínicos de 12 meses do protocolo brasileiro BRAVO. Métodos: O registro BRAVO foi um estudo prospectivo, não randomizado, de braço único, multicêntrico (25centros), que avaliou os resultados clínicos tardios de 535 pacientes minimamente selecionados, tratados com o stent farmacológico XIENCE V®.Resultados: Cerca de 40% dos pacientes tinham diabetes, 25% infarto agudo do miocárdio prévio e 42% apresentaram-se com síndrome coronária aguda. A maioria das lesões (69%) era de elevada complexidade(ACC/AHA tipo B2/C). As médias da extensão e do diâmetro nominais dos stents foram, respectivamente, 19,9 ± 5,3 mm e 3,0 ± 0,4 mm. Os sucessos angiográfico e de procedimento foram de 99,7 e 98%, respectivamente. Aos 12 meses, a taxa cumulativa de eventos cardíacos adversos maiores, disponível em 100% dos pacientes, foi de 5,6% (morte cardíaca: 1,3%; infarto agudo do miocárdio: 3,0%; revascularização da lesão-alvo: 2,2%). Já a trombose de stent ocorreu em cinco pacientes (0,9%), sendo reportada apenas uma ocorrência entre 6 e 12 meses. Conclusões: O stent farmacológico XIENCE V® demonstrou segurança e eficácia sustentadas ao final de 12meses no tratamento de lesões coronárias complexas em pacientes da prática diária...

The Xience VTM everolimus-eluting stents is a new generation drug-eluting stent (DES)that incorporates a low profile cobalt-chromium platform (81 m) and a highly biocompatible polymer(fluoropolymer), which carries and controls the release of everolimus. Recent studies have demonstrated sustained safety and efficacy of the Xience VTM in the treatment of real-world populations. Our aim was to report the clinical results of 12 months of the BRAVO Brazilian protocol. Methods: The BRAVO Registry was a prospective, non-randomized, single-arm, multicenter (25 centers) study that evaluated the late clinical results of 535 minimally selected patients treated with the drug eluting stent Xience VTM in Brazilian daily practice. Results: Overall, 40% of patients had diabetes, 25% prior myocardial infarction, and 42% presented with acute coronary artery syndrome. The majority of lesions (69%) was highly complex (ACC/AHA type B2 or C).The mean length and the nominal stent diameter were 19.9 ± 5.3 mm and 3.0 ± 0.4 mm, respectively.The angiographic and procedural successes were 99.7 and 98%, respectively. At 12 months, the cumulative rate of major adverse cardiac events, available in 100% of patients, was 5.6% (cardiac death: 1.3%; acute myocardial infarction: 3.0%; revascularization of the target lesion: 2.2%). Stent thrombosis occurred in 5 patients (0,9%), and only 1 case was reported between 6 and 12 months. Conclusions: The drug-eluting stent Xience V™ demonstrated sustained safety and efficacy up to 12 months in the treatment of complex coronary lesions in patients from daily practice...

Prevalence of Burnout Syndrome in Patients Admitted with Acute Coronary Syndrome / Prevalência da Síndrome de Burnout em Pacientes Hospitalizados com Síndrome Coronariana Aguda

Background: Burnout Syndrome is the extreme emotional response to chronic occupational stress, manifesting as physical and mental exhaustion. Although associated with higher prevalence of cardiovascular risk factors, no study so far has evaluated whether the Burnout Syndrome could be a prevalent factor in non-elderly individuals active in the labor market, admitted for acute coronary syndrome (ACS). Objective: To evaluate the prevalence of the Burnout Syndrome in non-elderly, economically active patients, hospitalized with ACS. Methods: Cross-sectional study conducted in a tertiary and private cardiology center, with economically active patients aged <65 years, hospitalized with diagnosis of ACS. The Burnout Syndrome was evaluated with the Burnout Syndrome Inventory (BSI), which assesses workplace conditions and four dimensions that characterize the syndrome: emotional exhaustion (EE), emotional distancing (EmD), dehumanization (De) and professional fulfillment (PF). The Lipp’s Stress Symptoms Inventory for Adults (LSSI) was applied to evaluate global stress. Results: Of 830 patients evaluated with suspected ACS, 170 met the study criteria, 90% of which were men, overall average age was 52 years, and 40.5% had an average income above 11 minimum wages. The prevalence of the Burnout Syndrome was 4.1%. When we evaluated each dimension individually, we found high EE in 34.7%, high De in 52.4%, high EDi in 30.6%, and low PF in 5.9%. The overall prevalence of stress was 87.5%. Conclusion: We found a low prevalence of Burnout Syndrome in an economically active, non-elderly population among patients admitted for ACS in a tertiary and private hospital. .

Fundamento: Síndrome de Burnout (SB) é a resposta emocional extrema ao estresse crônico ocupacional, manifestando-se como processo de esgotamento físico e psíquico. Embora associada com maior prevalência de fatores de risco, nenhum estudo avaliou até o momento se a SB poderia ser um fator prevalente em indivíduos não idosos, ativos no mercado de trabalho, admitidos por síndrome coronária aguda (SCA). Objetivo: Avaliar a prevalência da SB em pacientes economicamente ativos, não idosos, hospitalizados com diagnóstico de SCA. Métodos: Estudo transversal realizado em um centro de cardiologia terciário e privado, com pacientes economicamente ativos, com idade < 65 anos, hospitalizados com diagnóstico de SCA. Para avaliação da SB, aplicou-se o Inventário da Síndrome de Burnout (ISB), que avalia as condições do ambiente de trabalho e as dimensões que caracterizam a SB: exaustão emocional (EE), distanciamento emocional (DEm), desumanização (Des) e realização profissional (RP). Aplicou-se ainda o Inventário de Sintomas de Stress para Adultos de Lipp (ISSL) para avaliação de estresse global. Resultados: Dos 830 pacientes avaliados com suspeita de SCA, 170 preencheram os critérios do estudo, sendo 90% homens, com idade média de 52 anos, e rendimento médio acima de 11 salários mínimos em 40,5% da amostra. A prevalência da SB foi de 4,1%. Elevada EE esteve presente em 34,7%, elevado DEm em 52,4%, elevada Des em 30,6% e baixa RP em 5,9%. A prevalência de estresse geral foi de 87,5%. Conclusão: A SB foi pouco prevalente em pacientes ativos no mercado de trabalho, não idosos, e internados por SCA nesta amostra avaliada em um hospital cardiológico privado e terciário. .

Prevalence of Burnout Syndrome in patients admitted with acute coronary syndrome.

BACKGROUND: Burnout Syndrome is the extreme emotional response to chronic occupational stress, manifesting as physical and mental exhaustion. Although associated with higher prevalence of cardiovascular risk factors, no study so far has evaluated whether the Burnout Syndrome could be a prevalent factor in non-elderly individuals active in the labor market, admitted for acute coronary syndrome (ACS). OBJECTIVE: To evaluate the prevalence of the Burnout Syndrome in non-elderly, economically active patients, hospitalized with ACS. METHODS: Cross-sectional study conducted in a tertiary and private cardiology center, with economically active patients aged <65 years, hospitalized with diagnosis of ACS. The Burnout Syndrome was evaluated with the Burnout Syndrome Inventory (BSI), which assesses workplace conditions and four dimensions that characterize the syndrome: emotional exhaustion (EE), emotional distancing (EmD), dehumanization (De) and professional fulfillment (PF). The Lipp's Stress Symptoms Inventory for Adults (LSSI) was applied to evaluate global stress. RESULTS: Of 830 patients evaluated with suspected ACS, 170 met the study criteria, 90% of which were men, overall average age was 52 years, and 40.5% had an average income above 11 minimum wages. The prevalence of the Burnout Syndrome was 4.1%. When we evaluated each dimension individually, we found high EE in 34.7%, high De in 52.4%, high EDi in 30.6%, and low PF in 5.9%. The overall prevalence of stress was 87.5%. CONCLUSION: We found a low prevalence of Burnout Syndrome in an economically active, non-elderly population among patients admitted for ACS in a tertiary and private hospital.

Resultados clínicos tardios do stent farmacológico liberador de sirolimus firebird® no tratamento de pacientes com doença arterial coronária na prática diária: seguimento de 24 Meses do registro CLARIFIRE / Late clinical outcomes of firebird™ sirolimus-eluting stent for the treatment of coronary artery disease in daily practice – 24-month follow-up of the CLARIFIRE registry

Introdução: O stent farmacológico liberador de sirolimus Firebird® já demonstrou eficácia na inibição de hiperplasia neointimal em pacientes selecionados submetidos à intervenção coronária percutânea. Nosso objetivo foi avaliar o desempenho e o resultado clínico tardio do dispositivo Firebird® em pacientes submetidos à intervenção coronária percutânea na prática diária nacional. Métodos: O Registro CLARIFIRE foi um estudo prospectivo, não randomizado, multicêntrico, que incluiu 455 pacientes (536 lesões) em 14 centros no Brasil entre dezembro de 2008 e maio de 2011. O seguimento clínico foi realizado aos 1, 6, 12 e 24 meses, e os eventos adversos foram adjudicados por um Comitê de Eventos Clínicos independente. Resultados: A média das idades foi de 61,1 ± 10,4 anos, 30,8% eram do sexo feminino, 41,9% tinham diabetes e 58,2% apresentaram-se com angina estável. O vaso-alvo mais prevalente foi a artéria descendente anterior (46,5%), 29,9% eram lesões reestenóticas e 8% lesões em bifurcação. Foram implantados 613 stents e as médias de extensão e diâmetro nominal dos stents foram 22,0 ± 6,4 mm e 2,90 ± 0,40 mm, respectivamente. O sucesso do procedimento foi de 97,6%. A taxa cumulativa de eventos cardíacos adversos maiores aos 12 meses (desfecho primário) foi 8,1%. Considerando-se os eventos pós-hospitalização até 24 meses (409/455), observaram-se eventos cardíacos adversos maiores em 9,8%, morte cardíaca em 3,9% e revascularização do vaso-alvo em 7,6%. Já a trombose de stent (definitiva/provável) ocorreu em nove casos (2%) até 30 dias, sem ocorrências subsequentes. Conclusões: O stent farmacológico liberador de sirolimus Firebird ® demonstrou desempenho favorável, Além de segurança e eficácia sustentadas no tratamento de pacientes da prática diária, conforme evidenciado pela elevada taxa de sucesso do procedimento e pela ocorrência relativamente baixa de eventos adversos ao final de 2 anos...

Background: The Firebird™ sirolimus-eluting stent has proven to be effective in inhibiting neointimal hyperplasia in selected patients undergoing percutaneous coronary intervention. Our objective was to evaluate the performance and long-term outcomes of Firebird ™ in patients undergoing percutaneous coronary intervention in daily practice in Brazil. Methods: The CLARIFIRE Registry was a prospective, non-randomized, multicenter study enrolling 455 patients (536 lesions) in 14 Brazilian sites between December 2008 and May 2011. Clinical follow-up was performed at 1, 6, 12, and 24 months, and adverse events were adjudicated by the independent Clinical Events Committee. Results: Mean age was 61.1 ± 10.4 years, 30.8% were women, 41.9% had diabetes, and 58.2% had stable angina. The left anterior descending artery was the most prevalent target vessel (46.5%), 29.9% were restenotic lesions, and 8% were bifurcations. Six hundred and thirteen stents were implanted, and the mean nominal stent length and diameter were 22.0 ± 6.4 mm and 2.90 ± 0.40 mm, respectively. Procedural success was 97.6%. The cumulative major adverse cardiac events rate at 12 months (primary endpoint) was 8.1%. Considering post-discharge events up to 24 months (409/455), major adverse cardiac events were observed in 9.8%, cardiac death in 3.9%, and target vessel revascularization in 7.6% of the patients. Definite/probable stent thrombosis was observed in nine cases (2%) up to 30 days, and no further occurrences were found. Conclusions: The Firebird ™ sirolimus-eluting stent has demonstrated good performance and sustained safety and efficacy for patients treated in daily practice, as evidenced by the high procedural success rates and relatively low adverse event rates after 2 years...

Percutaneous management of left atrial appendage perforation during device closure.

A 76-year-old male patient was admitted for percutaneous left atrial appendage (LAA) closure because of chronic atrial fibrillation and a history of gastrointestinal bleeding under oral anticoagulation. The procedure was complicated by perforation of the LAA with the lobe of the closure device being placed in the pericardial space. Keeping access to the pericardial space with the delivery sheath, the LAA closure device was replaced by an atrial septal defect closure device to seal the perforation. Then the initial LAA closure device was reimplanted in a correct position. Needle pericardiocentesis was required but the subsequent course was uneventful.